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Non-steroidal anti-inflammatory ophthalmic compositions

a technology of ophthalmic compositions and non-steroidal anti-inflammatory agents, which is applied in the field of ophthalmic formulations, can solve the problems of drawbacks in the prior ophthalmic delivery system of bromfenac, and achieve the effects of reducing the risk of ophthalmic complications

Active Publication Date: 2014-07-15
SUN PHARMA INDS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes an ophthalmic composition that can be applied to the eye in various ways, such as through eye drops or injection. The composition contains a flowable mucoadhesive polymer that can gel in the eye to provide sustained release of the medicament. The composition can also contain other components such as bromfenac, a medicament commonly used to treat inflammation and other conditions of the eye. The patent also describes the ways in which the bromfenac can be associated with the polymer, such as being in solution or suspension. Overall, the patent provides a technical solution for delivering ophthalmic medications to the eye in a safe and effective way.

Problems solved by technology

Prior ophthalmic delivery systems for bromfenac have suffered drawbacks in one or more of those areas.

Method used

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  • Non-steroidal anti-inflammatory ophthalmic compositions
  • Non-steroidal anti-inflammatory ophthalmic compositions
  • Non-steroidal anti-inflammatory ophthalmic compositions

Examples

Experimental program
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Effect test

example 1

[0069]Polycarbophil (Noveon® AA-1) was slowly dispersed into a citrate buffer solution containing dissolved EDTA and sodium chloride at approximately 50% of the final batch size. The resulting dispersion, which had a pH of a bout 3.0 to 3.5, was stirred with an overhead stirrer until visibly well hydrated. The mixture was sterilized by autoclaving at 121° C. for 20 minutes. The pH was then brought up to approximately 4.0 to 4.4 with 2N sodium hydroxide. Bromfenac sodium was dissolved in a mannitol solution containing dissolved benzalkonium chloride and Poloxamer 407 at approximately 20% of the final batch size. The resulting solution was then sterile filtered (0.22 μm filter) in to the polymer dispersion and stirred for 10 minutes. The pH of the bromfenac-polymer dispersion was brought to 8.3 with 2N sodium hydroxide. Sterile make up water was added to the formulation to final weight and mixed for at least 5 minutes. The formulation was aseptically filled into 5 ml bottles. See Tabl...

example 2

[0071]In this example, the formulations of 0.09% and 0.045% bromfenac in DuraSite®, prepared according to Example 1, were compared with Xibrom® and Radio-Xibrom® in providing bromfenac to the aqueous humor of the eye in pigmented rabbits (n=6). In a first experiment, separately, the formulation of 0.09% bromfenac in DuraSite®, Xibrom® and Radio-Xibrom® (C carbon 14 labeled bromfenac in Xibrom from literature reference JOURNAL OF OCULAR PHARMACOLOGY AND THERAPEUTICS, 24(2), 2008, 392-398) were topically administered to pigmented rabbits in the amount of 1 drop per eye (approximately equal to about 25 microliters per eye). Xibrom was administered to one eye and the bromfenac DuraSite solution to the other. The concentrations of bromfenac in the aqueous humor of the eye were determined by removing the aqueous humor and measuring concentrations by LCMS (see FIG. 1A). In a second experiment, the bromfenac concentrations provided by 1 drop per eye of the formulation of 0.045% bromfenac in...

example 3

[0072]The formulation of 0.09% bromfenac in DuraSite®, prepared according to Example 1, was ophthalmically administered to pigmented rabbits in the same manner as Example 2, TID for a period of 14 days. At the end of the 14-day period, rabbits were sacrificed in accordance with the related regulatory and NIH guidelines for animal studies, and the concentration of bromfenac was measured using LCMS. In this experiment, the retina was separated from the choroid and tissue concentrations of bromfenac were measured. The concentration of bromfenac in the retina tissue from this 0.09% bromfenrac formulation on average, was found to be 34±10.4 ng per gram of tissue.

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Abstract

The disclosure provides compositions and systems for topical ophthalmic application, which include an aqueous mixture of bromfenac and flowable mucoadhesive polymer, for treating inflammation and inflammatory conditions of the eye.

Description

FIELD OF THE INVENTION[0001]The present invention relates to ophthalmic formulations; more particularly to ophthalmic formulations of nonsteroidal anti-inflammatory agents; more particularly the present invention relates to ophthalmic formulations of bromfenac.BACKGROUND OF THE INVENTION[0002]In topical administration of medicaments to the eye, a variety of factors can be important, among them: comfort, control, consistency and accuracy of dosage, type and time of any vision interference, ease of administration, and timing of delivery. Prior ophthalmic delivery systems for bromfenac have suffered drawbacks in one or more of those areas.SUMMARY OF THE INVENTION[0003]It is an object of the invention to provide a novel composition of bromfenac that can overcome any of the above drawbacks.[0004]The present invention provides topical ophthalmic formulations containing a non-steroidal anti-inflammatory agent, bromfenac, and a flowable mucoadhesive polymer. It has been discovered that the ...

Claims

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Application Information

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Patent Type & Authority Patents(United States)
IPC IPC(8): A61K31/196A61K9/00A61K31/192A61K45/06A61K47/32A61K47/34
CPCA61K31/192A61K9/0048A61K45/06A61K47/32A61K47/34A61P27/02A61K2300/00
Inventor HOSSEINI, KAMRANBOWMAN, LYLESI, ERWIN C.PHAM, STEPHEN
Owner SUN PHARMA INDS
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